[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Rules and Regulations]
[Pages 33085-33088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13160]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 310

[Docket No. FSIS-2020-0005]
RIN 0583-AD81


Elimination of the Requirement To Defibrinate Livestock Blood 
Saved as an Edible Product

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is removing from 
the Federal meat inspection regulations a requirement for the 
defibrination of livestock blood saved as an edible product. 
Defibrination is the process for removing the protein fibrin, which 
causes blood to clot. Removal of the defibrination requirement will not 
affect food safety, but it will allow the industry to meet a demand for 
non-defibrinated blood products.

DATES: This rule is effective August 23, 2021.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development, FSIS; 
Telephone: (202)-205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On June 1, 2020, FSIS proposed to remove from the Federal meat 
inspection regulations a provision requiring the defibrination of 
livestock blood saved as edible product (85 FR 33031). The Agency 
stated in the proposed rule that eliminating the requirement, along 
with its associated costs to industry, would not affect food safety, 
but would enable industry to meet a demand for non-defibrinated blood 
products.
    FSIS noted in the proposal that, before 1974, the regulations 
allowed establishments to collect edible blood from all livestock, 
except swine. However, in 1974, the Agency promulgated 9 CFR 310.20, 
which removed the swine blood prohibition, finding that it was not 
necessary for food safety (39 FR 1973, January 16, 1974). In the 1974 
rule, the Agency also reasoned that the prohibition was burdensome, in 
that it denied specialty food producers a source of swine blood for 
their products.
    Also, FSIS explained in the proposed rule that there had been no 
substantive changes governing the saving of livestock blood since 1974. 
Since that time, 9 CFR 310.20 has allowed establishments to save edible 
blood from all livestock, including swine, provided the animals' 
carcasses are inspected and passed and the blood is collected, 
defibrinated, and handled in a manner to prevent its becoming 
adulterated under the FMIA.
    FSIS examined the peer-reviewed literature on coagulated, i.e., 
non-defibrinated, blood and did not identify any scientifically 
supportable food safety concerns. Thus, FSIS believes coagulated blood, 
like fluid blood, is safe for human consumption, provided the blood is 
saved from inspected and passed animals, and the blood is otherwise 
produced and prepared in compliance with all other FSIS regulations. 
Therefore, FSIS believes the defibrination requirement is not necessary 
to ensure food safety in accordance with the FMIA.\2\
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    \2\ FSIS Notice 22-19 instructs inspection program personnel on 
how to verify that edible blood, including coagulated blood, is 
collected and handled in a manner to be fit for use in human food. 
FSIS will periodically review data generated by such verification 
activities to ensure that establishments are following proper food 
safety practices pertaining to the collection of edible blood.
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    Furthermore, as is explained in the proposed rule, FSIS has become 
aware that some establishments are interested in collecting coagulated 
blood for use in human food products, including specialty and ethnic 
food products, that require coagulated blood as an ingredient. Such 
foods include variations of blood sausage, blood pudding, and blood 
tofu. The current defibrination requirement denies specialty and ethnic 
food producers a source of coagulated blood, thereby placing an 
unnecessary economic burden on them and on the livestock slaughter 
establishments that could provide coagulated blood.
    FSIS proposed to remove the defibrination requirement from the 
Federal meat inspection regulations for many of the same reasons it 
gave for eliminating the swine blood prohibition in 1974.

Final Rule

    This final rule is consistent with the proposed rule. FSIS is 
making no additional changes to the regulations in response to 
comments. FSIS is removing the defibrination requirement from 9 CFR 
310.20.
    Specifically, FSIS is revising the codified regulations to remove 
the word ``defibrinated''. Under this final rule, official 
establishments will still have the option to defibrinate blood, 
provided they meet all other requirements in 9 CFR 310.20. The 
regulations will continue to prohibit the defibrination of blood by 
hand. The regulations will also continue to require the use of 
anticoagulants that meet cited requirements in title 9 and title 21 of 
the Code of Federal Regulations.

Comments and Response

    Comments: FSIS received two comments on the proposed rule. The 
first, from an industry association, was in agreement with the Agency's 
reasons for proposing to eliminate the blood defibrination requirement, 
including the lack of a food-safety benefit from the requirement and 
the fact that coagulated

[[Page 33086]]

blood is a key ingredient in certain ethnic cuisines.
    The second comment, from an individual, supported the practice of 
saving undefibrinated livestock blood as an edible product. The comment 
also underscored the benefits from eliminating the unnecessary costs 
associated with the defibrination requirement. The commenter stated 
that although these costs, as calculated in the Agency's economic 
analysis, may seem minimal when viewing a single employee performing a 
single defibrination task, they add up in the course of a year and when 
considering the number of establishments affected.
    Response: FSIS agrees with the commenters and appreciates their 
support for this deregulatory action.

Executive Orders (E.O.s) 12866 and 13563, and the Regulatory 
Flexibility Act

    E.O.s 12866 and 13563 direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). E.O. 13563 emphasizes the 
importance of quantifying both costs and benefits, of reducing costs, 
of harmonizing rules, and of promoting flexibility. This final rule has 
been designated as a ``non-significant'' regulatory action under 
section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed 
by the Office of Management and Budget (OMB) under E.O. 12866.
    FSIS has updated the estimated benefits for this final rule from 
those published in the proposed rule based on more recent data. The 
changes include: A slight increase in the number of askFSIS questions 
and establishments; updated wage rates for production employees; and 
updated anti-coagulant solution costs.

Baseline

    From October 2015 to December 2, 2020, FSIS received 16 askFSIS \3\ 
questions about defibrination from 15 slaughter establishments. 
Therefore, FSIS assumes that at least 15 establishments will be 
affected by this final rule.
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    \3\ askFSIS is a web-based computer application designed to help 
answer technical and policy-related questions from inspection 
program personnel, industry, consumer groups, other stakeholders, 
and the public. This data was received on December 2, 2020.
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Expected Costs of the Final Rule

    There are no expected costs associated with this final rule. FSIS 
will allow coagulated blood to be saved for edible purposes.

Expected Benefits of the Final Rule

    This final rule will benefit slaughter establishments that 
manufacture livestock blood and processing establishments that use the 
blood in their products, such as blood sausage, blood tofu, and blood 
pudding. This final rule will allow slaughter establishments 
manufacturing livestock blood for edible purposes to package and sell 
the item in its customary coagulated form, enhancing the marketability 
for these niche products. In addition, removing the unnecessary, 
prescriptive requirements will allow establishments additional 
flexibility to be innovative and to operate in the most efficient 
manner.
    Removing the regulatory requirement for establishments to 
defibrinate livestock blood is expected to result in industry cost 
savings. Establishments will reduce anti-coagulant solution costs and 
labor costs associated with defibrination.
    According to 9 CFR 424.21, sodium citrate is a FSIS-approved anti-
coagulant that can be used to defibrinate blood. FSIS estimates that 
the 2020 sodium citrate solution cost per gallon of blood is $1.47.\4\ 
Using askFSIS and Public Health Information System (PHIS) \5\ data, 
FSIS determined that all 15 establishments that process edible blood 
are small or very small establishments. FSIS experts estimated that 
small establishments that process edible blood products process two to 
five gallons of edible blood per production day. These establishments 
operate about 213 \6\ production days per year, which means that they 
each process an estimated 426 to 1,065 gallons of edible blood per 
year. Each of these establishments will save approximately $1,096 per 
year, with a range of $626 \7\ to $1,566 \8\ if they no longer 
defibrinate blood.
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    \4\ Sodium citrate prices were obtained from three laboratory 
websites, https://www.jorvet.com/, https://www.rpicorp.com/, https://www.tocris.com/. These websites were accessed on 11/30/2020.
    The average sodium citrate price per milliliter was $0.08. This 
price was multiplied by the conversion rate of 3,785.412 ml per 
gallon to get the average sodium citrate price per gallon of 
$292.11. According to 9 CFR 424.21, the sodium citrate solution 
cannot exceed 0.5 percent, based on the ingoing weight of the 
product. Therefore, the price of sodium citrate per gallon of blood 
would be $292.11 multiplied by .005 or $1.47.
    \5\ PHIS is FSIS's electronic data analytic system, used to 
collect, consolidate, and analyze data in order to improve public 
health. FSIS used data from (PHIS) to identify these establishments 
by Hazard Analysis and Critical Control Point (HACCP) category. This 
data was accessed on December 2, 2020.
    \6\ Viator. C. et al. 2015. RTI International ``Costs of Food 
Safety Investments'' prepared by Catherine L. Viator, Mary K. Muth, 
and Jenna E. Brophy. The contract number is No. AG-3A94-B-13-0003. 
The order number is AG-3A94-K-14-0056. Table 2-5. Available at 
http://www.fsis.usda.gov/wps/wcm/connect/0cdc568e-f6b1-45dc-88f1-45f343ed0bcd/Food-Safety-Costs.pdf?MOD=AJPERES.
    \7\ 426 gallons multiplied by $1.47, the sodium citrate cost per 
gallon of blood, equals $626. Costs are rounded to the nearest 
dollar.
    \8\ 1,065 gallons multiplied by $1.47 equals $1,566. Costs are 
rounded to the nearest dollar.
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    Establishments that process edible blood will also benefit from 
labor cost savings. FSIS experts estimate that it takes one production 
worker two to five minutes to defibrinate one gallon of livestock 
blood. FSIS estimated the total compensation rate of a production 
employee is $28.46 \9\ per hour or approximately $0.50 \10\ per minute 
based on 2019 estimates from the Bureau of Labor Statistics. Each 
establishment will save approximately $1,305 in labor costs per 
year,\11\ with a range of $426 to $2,663 if they no longer defibrinate 
blood.
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    \9\ Wage estimate of $14.23 obtained from the Bureau of Labor 
Statistics, May 2019 National Industry-Specific Occupational 
Employment and Wage Estimates for the Processing Workers 
(Occupational Code 51-3023) in the Animal Slaughtering and Process 
Industry (NAICS code 311600). https://www.bls.gov/oes/current/oes513023.htm. FSIS multiplied the mean hourly wage rate by a 
benefits factor of 2, to obtain a total compensation rate of $28.46 
per hour.
    \10\ $28.46 divided by 60 minutes equals $0.4743 rounded to the 
nearest tenth of a cent to $0.50.
    \11\ 3.5 ((2 + 5)/2) minutes multiplied by the mid estimate of 
3.5 ((2 + 5)/2) gallons of blood per production day multiplied by 
213 production days, multiplied by the labor cost per minute 
($0.50). The costs are rounded to the nearest dollar.
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    FSIS estimated that at least the 15 establishments that submitted 
askFSIS questions about defibrination from October 2015 to December 2, 
2020 will benefit from the cost savings associated with this final 
rule. The total estimated annual industry cost savings are detailed in 
Table 1.

                                 Table 1--Industry Annual Cost Savings Estimates
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                                                                        Low           Medium           High
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Sodium Citrate Cost Savings/Year................................          $9,390         $16,440         $23,490

[[Page 33087]]

 
Labor Cost Savings/Year.........................................           6,390          19,575          39,945
    Total Cost Savings..........................................          15,780          36,015          63,435
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    Total Costs Savings annualized at a discount rate of 7% over          15,780          36,015          63,435
     10 years...................................................
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Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a determination that this final 
rule will not have a significant economic impact on a substantial 
number of small entities in the United States, as defined by the 
Regulatory Flexibility Act (5 U.S.C. 601). Small and very small 
establishments will benefit from the cost savings associated with this 
final rule. However, the benefits to small and very small 
establishments, as indicated by the total savings estimates in Table 1 
($15,780 to $63,435 over 10 years), will not be significant. Of the 15 
establishments that submitted askFSIS questions about defibrination 
from October 2015 to December 2, 2020, about 67 percent were classified 
as small, by Hazard Analysis and Critical Control Point (HACCP) size, 
and 33 percent were HACCP-size very small. Under the HACCP-size 
definitions, large establishments have 500 or more employees and small 
establishments have fewer than 500 but more than 10 employees. Very 
small establishments have fewer than 10 employees or annual sales of 
less than $2.5 million.

Paperwork Reduction Act

    There are no new paperwork or recordkeeping requirements associated 
with this final rule under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).

Environmental Impacts

    Each USDA agency is required to comply with 7 CFR part 1b of the 
Departmental regulations, which supplements the National Environmental 
Policy Act regulations published by the Council on Environmental 
Quality. Under these regulations, actions of certain USDA agencies and 
agency units are categorically excluded from the preparation of an 
Environmental Assessment (EA) or an Environmental Impact Statement 
(EIS) unless the agency head determines that an action may have a 
significant environmental effect (7 CFR 1b.4(b)). FSIS is among the 
agencies categorically excluded from the preparation of an EA or EIS (7 
CFR 1b.4(b)(6)).
    FSIS has determined that this final rule, which removes the 
defibrination requirement from 9 CFR 310.20, will not create any 
extraordinary circumstances that would result in this normally excluded 
action's having a significant individual or cumulative effect on the 
human environment. Therefore, this action is appropriately subject to 
the categorical exclusion from the preparation of an environmental 
assessment or environmental impact statement provided under 7 CFR 
1b.4(6) of the U.S. Department of Agriculture regulations.

E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the internet and other information technologies 
and providing increased opportunities for citizen access to Government 
information and services, and for other purposes.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, the USDA, its 
Agencies, offices, and employees, and institutions participating in or 
administering USDA programs are prohibited from discriminating based on 
race, color, national origin, religion, sex, gender identity (including 
gender expression), sexual orientation, disability, age, marital 
status, family/parental status, income derived from a public assistance 
program, political beliefs, or reprisal or retaliation for prior civil 
rights activity, in any program or activity conducted or funded by USDA 
(not all bases apply to all programs). Remedies and complaint filing 
deadlines vary by program or incident.
    Persons with disabilities who require alternative means of 
communication for program information (e.g., Braille, large print, 
audiotape, American Sign Language, etc.) should contact the responsible 
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or 
contact USDA through the Federal Relay Service at (800) 877-8339. 
Additionally, program information may be made available in languages 
other than English.
    To file a program discrimination complaint, complete the USDA 
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and 
at any USDA office or write a letter addressed to USDA and provide in 
the letter all of the information requested in the form. To request a 
copy of the complaint form, call (866) 632-9992. Submit your completed 
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, 
Office of the Assistant Secretary for Civil Rights, 1400 Independence 
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) 
email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Constituent Update is available on the FSIS web page. 
Through the web page, FSIS is able to provide information to a much 
broader, more diverse audience. In addition, FSIS offers an email 
subscription service which provides automatic and customized access to 
selected food safety news and information. This service is available 
at: https://www.fsis.usda.gov/subscribe. Options range from recalls to 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves and have the

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option to password-protect their accounts.

List of Subjects in 9 CFR Part 310

    Meat and meat products, Blood.

    For the reasons set forth in the preamble, FSIS amends 9 CFR 
chapter III as follows:

PART 310--POST-MORTEM INSPECTION

0
1. The authority citation for part 310 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


0
2. Revise Sec.  310.20 to read as follows:


Sec.  310.20  Saving of blood from livestock as an edible product.

    Blood may be saved for edible purposes at official establishments 
provided it is derived from livestock, the carcasses of which are 
inspected and passed, and the blood is collected and handled in a 
manner so as not to render it adulterated under the Federal Meat 
Inspection Act and regulations issued pursuant thereto. The 
defibrination of blood intended for human food purposes shall not be 
done with the hands. Anticoagulants may be used in accordance with 21 
CFR chapter I, subchapter A and subchapter B, or by regulation in 9 CFR 
chapter III, subchapter A or subchapter E.

    Done, at Washington, DC.
Paul Kiecker
Administrator.
[FR Doc. 2021-13160 Filed 6-23-21; 8:45 am]
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